A Multicenter, Randomized, Controlled Study To Evaluate The Efficacy And Safety Of Short-Term Plasma Exchange Followed By Long-Term Plasmapheresis With Human Albumin Combined With Intravenous Immunoglobulin In Patients With Mild-Moderate AD

A clinical trial comprised of 350 subjects with probable mild to moderate Alzheimer's Disease (AD) will be conducted primarily to determine whether plasmapheresis with infusion of human albumin combined with Intravenous immunoglobulin (IVIG) is able to modify patient's cognitive, functional, behavioral and global domains. There will be 3 treatment groups and one control group. The subjects will be randomized in a 1:1:1:1 proportion.

Eligibility

Ages Eligible for Study:

55 Years to 85 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Main Inclusion Criteria:

Males or females between 55-85 years of age at the time of signing of the informed consent document.

A diagnosis of Alzheimer's disease (NINCDS-ADRDA criterion), and MMSE score between >/=18 and </=26.

Current stable treatment with AChEIs and/or memantine for the previous three months.

The patient and a close relative or the legal representative must read the patient information sheet, agree to participation in the trial, and then sign the informed consent document (the patient personally and the close relative/legal representative).

The patient must be able to follow the study protocol, receive the treatment in the established time period, and continue during the follow-up interval.

A brain CAT or MRI study obtained in the 12 months prior to screening, showing the absence of cerebrovascular disease, must be available. Neverthess, it is possible to use the MRI obtained during the screening to rule out any cerebral vascular disease.

A stable care taker must be available, and must attend the patient study visits.

Main Exclusion Criteria:

Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as for example:

Participation in other clinical trials, or the receiption of any other investigational drug in the three months prior to the start of the study.

Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, known drug or alcohol abuse, etc.).

Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.

Fewer than six years of education (exclusion criteria under medical criterion).

Fewer than three months with stable treatment for behavioral disorders or insomnia.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561053